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     144  0 Kommentare Letter to AB Science stakeholders on COVID-19 pandemic impact on AB Science clinical studies

    Paris, April 07, 2020, 6.15pm

    A letter to our stakeholders on COVID-19 pandemic impact on AB Science clinical studies

    Dear Stakeholders,

    At this time, we expect that the COVID-19 pandemic will have limited impact on our clinical development program, as this crisis struck at a time when most of our on-going clinical studies were completed and new confirmatory studies were not yet initiated.

    Data integrity is not affected for any of our programs as a result of the pandemic. The only trial with patients still under treatment is our phase 3 trial in prostate cancer (AB12003). In this study, we continue to work closely with our contract research organizations to monitor the safety of patients who are participating in the study. We have not observed any discontinuations nor deaths due to COVID-19.

    For the studies to be read out, phase 2b/3 Alzheimer’s Disease AB9004, phase 3 Severe Asthma with High Eosinophils AB14001, phase 3 Pancreatic Cancer AB12005 and phase 3 Metastatic Prostate Cancer AB12003, the potential impact could be a delay of up to a couple of months in study read-out timing, due to more difficult access to the clinical sites to perform quality control checks before the database lock.

    For the new phase 3 Mastocytosis (AB15001) and ALS (AB19001) confirmatory studies, patient enrollment will start once post-pandemic conditions permit proper access to the sites, which may delay the enrollment date initially planned in March 2020 by up to 3 months. This decision is necessary to ensure the safety and well-being of our employees, the patients and the healthcare professionals involved in our clinical trials, and to ensure the integrity of these trials.

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    AB Science remains in constant contact with our global network of key suppliers, manufacturing partners, and contract research organizations to identify potential risks and take appropriate measures to avoid any disruption. At this time, we do not anticipate any supply disruptions.

    We have put into place remote operations and new policies to maintain the safety and well-being of our employees, in line with international COVID guidelines, while working to maintain business continuity.

    We wish you well in these difficult times.

    Alain Moussy
    CEO

    About AB Science
    Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.

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    Letter to AB Science stakeholders on COVID-19 pandemic impact on AB Science clinical studies Paris, April 07, 2020, 6.15pm A letter to our stakeholders on COVID-19 pandemic impact on AB Science clinical studies Dear Stakeholders, At this time, we expect that the COVID-19 pandemic will have limited impact on our clinical development …